Comparing the Complications of Three Methods of Furosemide Administered to Premature Neonates Suffering from Patent Ductus Arteriosus

Last registered on May 06, 2016
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Pre-Trial

Trial Information

General Information

Title
Comparing the Complications of Three Methods of Furosemide Administered to Premature Neonates Suffering from Patent Ductus Arteriosus
RCT ID
AEARCTR-0001222
Initial registration date
May 06, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 06, 2016, 7:44 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Iran (Islamic Republic of)
Region

Primary Investigator

Name
Mohammad Gharehbeglou
Affiliation
Islamic Azad University
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2015-01-01
End date
2016-02-01
Keywords
Health
Additional Keywords
JEL code(s)
Secondary IDs
Abstract
Abstract
Background: Patent dactus arteriosus (PDA) needs treatment for cases whose ducts are not closed spontaneously. Furosemide reduces preload, but there is still controversy regarding the protocol of its administration between pediatricians and pediatric cardiologists. We aimed to compare renal complications and electrolyte imbalance of three protocols of administering furosemide.
Methods: In this prospective study, 127 preterm neonates with PDA were randomly assigned into three different groups: 2 mg/kg very slow infusion Furosemide was given intravenously to 47 neonates slow infusion every other day (group A), 1 mg/kg very slow infusion to 39 neonates every day (group B), and 0.5 mg/kg per dose bolus doses twice a day to 41 neonates (group C) for about 14 days. Then, all participants underwent kidney ultrasonography. Blood and urine samples were taken from them on day 3 and 17. Data were analyzed by SPSS software.
Results: Electrolyte imbalance included higher sodium and calcium on the third day in group A (P<0.05) with no difference in serum level of potassium, PH, and HCO3. The serum level of calcium and Ca/Cr ratio was higher in group A (P<0.05) and serum level of BUN was higher in group B (P<0.05). Also, higher serum level of calcium and Ca/Cr ratio was observed on the seventeenth day in group A. Nephrocalcinosis was observed in 8.7% of neonates on the seventeenth day after furosemide with normal level of creatinine (P=0.896).
Conclusion: Administering furosemide in two bolus doses is superior regarding electrolyte imbalance and BUN levels, but nephrocalcinosis was not found to be different in three protocols.
External Link(s)

Registration Citation

Citation
Gharehbeglou, Mohammad. 2016. "Comparing the Complications of Three Methods of Furosemide Administered to Premature Neonates Suffering from Patent Ductus Arteriosus." AEA RCT Registry. May 06. https://doi.org/10.1257/rct.1222-1.0
Former Citation
Gharehbeglou, Mohammad. 2016. "Comparing the Complications of Three Methods of Furosemide Administered to Premature Neonates Suffering from Patent Ductus Arteriosus." AEA RCT Registry. May 06. https://www.socialscienceregistry.org/trials/1222/history/8126
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
In this prospective study, 127 preterm neonates who were diagnosed with PDA by a pediatric cardiologist were randomly assigned into three different groups by convenient sampling method: Group A (n=47) received a very slow infusion of 2 mg/kg Furosemide every other day, Group B (n=39) received a very slow infusion of 1 mg/kg Furosemide every day, and Group C (n=41) received 0.5 mg/kg per dose of Furosemide twice a day for about 14 days. Therefore total furosemide doses were similar in the 3 groups. Then, all participants underwent kidney ultrasonography that was performed and reported by one radiologist. Blood and urine samples were taken from all participants on day 3 and 17 after intervention (three protocols of administering furosemide). The blood samples were sent to a single laboratory and serum levels of sodium and calcium, urine Ca/Cr, and BUN, potassium, PH and HCO3 were assessed. Demographic data were collected include body weight, gestational age, and sex.
Intervention Start Date
2015-03-01
Intervention End Date
2016-02-01

Primary Outcomes

Primary Outcomes (end points)
Electrolyte imbalance included higher sodium and calcium on the third day in group A (P<0.05) with no difference in serum level of potassium, PH, and HCO3. The serum level of calcium and Ca/Cr ratio was higher in group A (P<0.05) and serum level of BUN was higher in group B (P<0.05). Also, higher serum level of calcium and Ca/Cr ratio was observed on the seventeenth day in group A. Nephrocalcinosis was observed in 8.7% of neonates on the seventeenth day after furosemide with normal level of creatinine (P=0.896).
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
In this prospective study, 127 preterm neonates who were diagnosed with PDA by a pediatric cardiologist were randomly assigned into three different groups by convenient sampling method: Group A (n=47) received a very slow infusion of 2 mg/kg Furosemide every other day, Group B (n=39) received a very slow infusion of 1 mg/kg Furosemide every day, and Group C (n=41) received 0.5 mg/kg per dose of Furosemide twice a day for about 14 days. Therefore total furosemide doses were similar in the 3 groups. Then, all participants underwent kidney ultrasonography that was performed and reported by one radiologist. Blood and urine samples were taken from all participants on day 3 and 17 after intervention (three protocols of administering furosemide). The blood samples were sent to a single laboratory and serum levels of sodium and calcium, urine Ca/Cr, and BUN, potassium, PH and HCO3 were assessed. Demographic data were collected include body weight, gestational age, and sex.
Ethical considerations:
The study protocol was in compliance with the Declaration of Helsinki (1989 revision) and was approved by the Local Medical Ethics Committee of Islamic Azad University in Iran (ID Number:
18334591-Q).
Experimental Design Details
Randomization Method
The participants were randomly assigned, following simple randomization procedures (1 : 1),
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
127
Sample size: planned number of observations
1
Sample size (or number of clusters) by treatment arms
127 patient
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Islamic Azad University
IRB Approval Date
2015-01-01
IRB Approval Number
18334591-Q
Analysis Plan

Post-Trial

Post Trial Information

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials